Determination of clindamycin phosphate in extemporaneously prepared pessaries with glycerol-gelatin basis

Abstract

Pessaries with clindamycin phosphate as active component were prepared by moulding. Glycerol-gelatin basis was used as the hydrophilic basis. The pessaries were made with and without the surface-active agent Tween 80 as an excipient. The content of clindamycin phosphate in all samples was determined by high performance liquid chromatography (HPLC) based on the calibration curve of clindamycin phosphate standard solution. The clindamycin phosphate content in the glycerol-gelatin pessaries with or without Tween 80 was optimal. Preparation of extemporaneous (magistral) medicines provides personalization of therapy and the possibility of selection of the most appropriate basis for the specific active substance, which also influences the effectiveness of the therapy. The active substance content in the magistral preparations is not subject to veri-fication in the everyday pharmacy practice. However, by validating the technological process of manufacture and by controlling the quality of the obtained preparations, the choice of the basis in the magistral medicine preparation can be optimized. In this manner, the guidelines for the galenic preparation, including pessaries, can be given to ensure their optimal therapeutic effect.